drugset / Trial / NCT03515538

Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers

NCT03515538

Phase 2 Completed 53 enrolled EpicentRx, Inc. Prothex, Inc. · collab
RandomizedParallel-groupOpen-labelSupportive care

Summary

The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the duration or length of severe oral mucositis in patients with head and neck cancers. All patients in this study will receive 7 weeks of standard of care radiation therapy given with the chemotherapy agent, cisplatin. Patients in arms 1, 2 and 3 will also receive RRx-001 on different schedules.

Timeline

Start
2018-07-12
Primary completion
2019-10-22
Completion
2020-10-08

Drugs

EvaluationDrugModalityDoseRoute
Subject NIBROZETONE Other / unclassified
Background Cisplatin Other / unclassified 100 mg/m2 Intravenous